TELAMON®
`Posterior Impacted Fusion Devices
`
`MINIMAL ACCESS SPINAL TECHNOLOGIESSM
`
`1
`
`MMSD 1108
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 1 of 10
`
`

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`Table of Contents
`
`Page 2
`
`Preoperative Planning and Patient Positioning
`
`Page 2
`
`Dilation/Tubular Retraction
`
`Page 3
`
`Tubular Retraction Insertion
`
`Page 3
`
`Discectomy
`
`Page 4
`
`Disc Space Distraction
`
`Page 4
`
`Disc Space Distraction – Rotate Cutter
`
`Page 5
`
`Disc Space Preparation – Round Scraper
`
`Page 5
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`Endplate Preparation – Cutting Chisel
`
`Page 6
`
`Removal of Cutting Chisels
`
`Page 6
`
`Cage Insertion
`
`Page 7
`
`Cage Insertion
`
`Page 8
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`Stabilization
`
`Page 9
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`Notes
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`2
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`1
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 2 of 10
`
`

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`Preoperative Planning
`
`Spinal needle is placed into
`paraspinous musculature 2-2.5cm
`off of midline at the appropriate level
`confirmed using lateral fluoroscopy.
`• The spinal needle is removed and
`a vertical incision is made at the
`puncture site.
`• The Guidewire is placed through
`the incision and directed toward
`the inferior aspect of superior
`lamina under lateral fluoroscopy.
`
`Dilation/Tubular Retraction
`
`Insert initial cannulated soft tissue
`Dilator over the Guidewire. Once the
`fascia is penetrated, remove the
`Guidewire and advance the Dilator
`down to the inferior edge of superior
`lamina. Confirm the placement of
`initial Dilator using lateral fluoroscopy.
`• Use the initial Dilator to palpate
`the lamina in both the coronal and
`sagittal planes.
`• The tip of the Dilator is used to
`sweep the paraspinal musculature
`off the laminar edge.
`• This maneuver affirms coronal
`placement and expedites soft
`tissue removal.
`• The second, third, fourth and fifth
`Dilators are placed over the initial
`Dilator down to the lamina.
`• Use depth markings on the Dilator
`to determine the correct Tubular
`3
`Retractor length.
`
`2
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 3 of 10
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`

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`Tubular Retraction Insertion
`
`• The Flexible Arm is attached to the
`Tubular Retractor.
`• The Tubular Retractor is placed over
`the sequential Dilators, docking on
`the lamina.
`• It is important to always apply
`downward pressure while adjusting
`the Flexible Arm.
`• Repeat muscle dilation and place
`the second Working Channel on the
`opposite side.
`• Fluoroscopy is used to confirm
`appropriate positioning.
`
`Discectomy
`
`• A conventional discectomy is
`performed by incising the annulus
`with a 15-scalpel blade lateral to the
`dural sac.
`• This is done bilaterally and then soft
`fragments from the intradiscal space
`or extruded fragments are removed
`with Disc Rongeurs in a conventional
`fashion.
`The main goal of this step is to remove
`extruded fragments, to decompress
`neural elements, and to provide entry
`to the disc space for distraction with
`minimal or no nerve root retraction.
`If there is significant disc space
`collapse, a complete discectomy may
`not be possible until disc space
`distraction is accomplished.
`
`First Dilator
`Insertion
`
`Sequential Dilation
`and Tubular Retractor Insertion
`
`Soft Tissue Removal
`
`Ligamentum Flavum Removal
`
`Nerve Root Retraction
`
`Discectomy
`
`4
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`3
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 4 of 10
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`

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`Disc Space Distraction
`
`The disc space is sequentially
`distracted until original disc space
`height is obtained and normal
`foraminal opening is restored.
`• Insert the Distractor with the
`T-handle attached, with the flat
`surface parallel to the endplates.
`• Rotate the Distractor 90 degrees
`to distract the space and remove
`the T-handle.
`• Sequentially insert Distractors from
`side to side until the desired height
`is obtained.
`• The largest Distractor is left in
`the disc space in the distracted
`position while continued disc space
`preparation is performed.
`
`Disc Space Preparation - Rotate Cutter
`
`• The smallest Rotate Cutter is inserted
`into the disc space with the cutting
`blades parallel to the dural sac.
`• The Rotate Cutter is rotated once or
`twice at a depth of 20mm to remove
`osteophytes at the dorsal endplate.
`Removing osteophytes facilitates
`placement of the Cutting Chisel later
`in the procedure.
`• The Rotate Cutter is then inserted up
`to a depth of 30mm and rotated to
`remove residual intradiscal material.
`
`4
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`5
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 5 of 10
`
`

`

`Disc Space Preparation - Round Scraper
`
`• Remaining soft tissue or cartilaginous
`endplate covering are removed with
`vigorous scraping or curettage.
`• Scrape medially under the midline
`and gradually work laterally in a
`sweeping motion until both caudal
`and cephalad endplates are cleared of
`soft tissue.
`• The removal of the soft tissue from
`the endplate surface allows optimal
`graft incorporation.
`
`Endplate Preparation - Cutting Chisel
`
`**Keep in mind to chisel to a depth that allows for the
`length of the graft plus 3mm to 4mm of countersink.
`To implant a 20mm graft, the surgeon should chisel
`to 30mm which allows for the length of the graft,
`countersink, and the 5mm lateral extensions.
`To insert a 26mm graft, repeat the
`process and insert the Chisel to a
`depth of 35mm.
`
`• With the dura protected or minimally
`retracted, the lateral extensions of
`the Cutting Chisel are seated into the
`disc space.
`• Place the lateral edge of the Cutting
`Chisel on or lateral to the mid-
`sagittal line of the pedicle.
`• The Chisel is impacted into the disc
`space. The cutting blades will remove
`the residual osteophytes and create
`an optimal bed to receive the wedge.
`**It is important to note that the depth markings on
`the Chisel are the actual depth of the instrument
`NOT what it is actually cutting. The leading edge
`of the lateral extensions are 5mm. If the Chisel is
`inserted to the 30mm depth mark, the blade of the
`instrument is actually cutting only 25mm of depth.
`
`6
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`5
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 6 of 10
`
`

`

`Removal of Cutting Chisels
`
`• After impacting the Cutting Chisel up to a
`depth of 30mm, attach the Slap Hammer to
`the Chisel handle and rotate 90 degrees and
`remove the Chisel with a repeated gentle
`upward stroke.
`
`Cage Insertion
`
`• The implant should be packed with
`bone grafting material either before or
`during this step. Typically, cancellous
`bone taken from the iliac crest is used.
`• The appropriate size cage is firmly
`attached to the Inserter.
`• Gently impact the cage down the
`previously prepared channel until it is
`3 to 4mm below the posterior margin.
`• Care should be taken to ensure the
`cage is aligned properly so that
`it travels down the previously
`created track.
`
`6
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`7
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 7 of 10
`
`

`

`Cage Insertion
`
`• Once the cage has been inserted,
`the first Disc Distractor is removed.
`• The second cage is inserted into the
`disc space along the previously
`prepared track.
`
`8
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`7
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 8 of 10
`
`

`

`Stabilization
`
`• After the final cage is placed, the extradural space and foramina are probed to ensure adequate
`decompression of the neural elements.
`• To facilitate satisfactory immobilization of the grafted interspace, segmental internal fixation is
`applied using standard technique.
`
`8
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`9
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 9 of 10
`
`

`

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`
`10
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`MEUMXTPST03
`
`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1011, p. 10 of 10
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